CA1329348C - Transtracheal catheter system and method - Google Patents

Abstract

ABSTRACT OF THE DISCLOSURE
A system for continuously supplying supplemental therapeutic oxygen to a patient to enhance atmospheric breathing comprising an oxygen supply source for continuous-ly supplying low pressure low volume oxygen to a patient at relatively low pressures and relatively low flow rates to supplement normal atmospheric breathing; flexible oxygen supply tube devices for supplying oxygen from said oxygen supply source to the patient and a continuous one-piece constant diameter flexible elongated tracheal tube member having a continuous constant diameter passage extending therethrough and being flexible when inserted into an operative position within the trachea to provide therein an intermediate curved side wall portion extending between a proximate end side wall portion having an unrestricted inlet opening therein located posterior of the neck of a patient and a straight distal side wall portion located in the trachea and extending downwardly therein and having an unrestricted distal end outlet opening located in upwardly spaced relationship to the bronchial tubes of the patient.

Description

~ 3~9~8 This invention pertains to a system for supple~ental transtracheal oxygen therapy including transtracheal cathe-ter devices ~or providing transtracheal, oxygen delivery for spontineously breathing patients with chronic lung disease and to methods ~or catheter place~ent and u~e SUCh devices are medically desirable therapy for patients having a chronic need for oxygen where a catheter can be installed on an out-patient basio for permanent use A~ a result of studies that date bac~ to the 1930's and 10 partioularly Btudies conducted in the ~960's and early lg70's, lt ha~ been determined that long-term continuous oxygen therapy is beneficial ln the treatment of hypoxemic patl-nts wlth chronlc ob~tructlv- pulmonary di~ease (COPD) In other words, a patlent~s ll~e and quality o~ e can be 15 improv-d by provlding a conotant supplemental BUpply of oxygen to the patlent's lungo ' 1 3293~8 However, with the current desire to contain medical costs, there is a growing concern that the additional cost of providing continuous oxygen therapy for chronic lung disease will create an excessive increase in the annual cost of oxygen therapy. Thus, it now desirable that oxygen therapy, when provided, be as cost effective ~s possible.
The standard treatment ~or patients requiring supple-mental oxygen is still to del~ver oxygen from an oxygen source by means Or a nasal cannula. Such treatment, how-ever, requires a large amount o~ oxygen, which is wastefuland can cause soreness and irritation to the nose, as well as being potentially aggravating. Other undesirable effects have also been reported. Various other medical approaches which have been proposed to help reduca the cost of con-tinuous oxygen therapy have been studied.
Various devices and methods have been devised forperforming emergency cricothyroidotomies and ~or providing a tracheotomy tube 80 that a patient whose airway is otherwise blocked may continue to breath. Such devices, are generally intended only ror use with a patient who i8 not breathing spontaneously and are not suitable for the long term treat-ment Or chronic lung disease. Typically, such devices are installed by puncturing the skin to create a hole into the cricoid membrane o~ the larynx above the trachea into which a relatlvely larg- curved tracheotomy tube i~ lnserted. As previou~ly de~cribed, th- use Or such tubes has been re-strlcted ~-dlcally to em-rgency ~ituation~ where the patlent would otherwi~e surrocate due to the blockage Or the airway.
Such emergency tracheotomy tubes are not ~uitable ~or long term therapy a~ter the airway blockage is removed.

other devices whlch have been ~ound ~atisractory ror emergency or ventilator use are descrlbed ln U S Patent No 953,922 to ~ogers; U S Patent No 2,873,742 to Shelden;
U S Patent No 3,384,087 to ~rummelkamp; U S Patent No 05 3,511,243 to Toy; U S Patent No 3,556, 103 to Calhoun;
U S Patent No 2,991,787 to Shelden, et al; U S Patent No 3,688,773 to Wels~; U s Patent No 3,817,250 to Wei~s, et al ; and U S Patent No 3,916,903 to Pozzl Although tracheoto~y tubes are satls~actory for their intended purpo~e, they are not intended ~or chron~c usage by outp~tlents ~s ~ me~ns ~or dellv~rlng supplemental oxygen to spontaneously breathlng patients with chronic obstructive pulmonary disease (COPD) Such tracheotomy tubes are generally designed so a8 to provide the total alr supply to the patlent for a relatlvely short perlod of tlne The tracheotomy tubes are generally o~ rlgld or seml-rlgld constructlon and Or callb-r ranglng rrom 2 5 ; outslde dia~-t-r ln ln~ants to 15 r~ outslde dlameter ln adults They ar- nor~ally lnserted ln an operatlng roo~ aB a urgi-cal procedure or durlng m-rgoncy sltuatlons, through the crlco-thyrold ~e~bran- where th- tissu- 1B less va w ular and th- po--lblllty o~ bl--dlng ls reduced These d-vlce~ are lnt-nd-d to p-rult pa~sage Or alr ln both dlr-ctlons untll nor a~ br-athlng ha- b--n restor-d by other ~-an-Anoth-r typ- o~ trach-otony tub- 1~ dl-clos-d ln Jaaob-, U 8 Pat-nt No 3,682,166 and U S Pat-nt No 3,788,,326 Th- cath-t-r d-~crlb-d th-r-ln 1- plac-d ov-r 14 or 16 gaug- n--dl- and lns-rt-d through th- crlco-thyrold ` ne~bran- ~or upplylng alr or oxyg-n and vacuu~ on an emerg-ncy basl~ to re~tore th- br-athlng o~ a non-breathlng patl-nt Th- alr or oxygen 18 uppll-d at 30 to 100 p-l ~or inflatlon and de~latlon o~ the patlent' 8 lungs . The Jacobs catheter, like the other tracheotomy tubes previously used, is not suitable for long term outpatient use, and could not easily be adapted to such use 05 Due to the llmited ~unctlonality of tracheotomy tubes, transtracheal catheters have been proposed and used ~or long term supplemental oxygen therapy For ex~mple the sm~ll dlameter tran6tracheal catheter (16 gauge) developed by Dr Henry J Helmllch ~de-cribed ln THE ANNALS OF OTOLOGY, R~INO~OGY ~ LARYNGOLOGY, Nov -Dec 1982; Re~piratory Reha-bilitatlon with Transtracheal Oxygen System) has been used by the lnsertion o~ a relatively large cutting needle (14 gauge) into the trachea at the mld-point between the crico-thyroid ~embrane and the sternal notch This cathater size can supply oxygen up to about 3 litere per minute at low pressures, such as 2 p~l whlch may be insu~icient ~or patients who require higher rlow rates It doe~ not, however, lend its01r to outpatlent use and ~aintenance, such as periodic removal and cleaning, primarily because the connector b-tween the catheter and the oxygen supply hose is ad~acent and again~t th- anterlor portion Or the trachea and cannot be ea-ily ~een and ~anlpulat-d by the patlent Further~or-, th- cath-t-r 1- not provided with po~itive ~-an- to protect agaln-t klnking or collap~ing which would pr-v-nt lt- rr-ctiv- us- on an out pati-nt ba-i- Such a r-atur- i- not only de~irable but necessary ror long t-rm, out ~atl-nt and ho~e car- u~- al~o, bocau-- Or lt~ truc-tur~ only one xlt openlng, the oxyg-n rrOm the cath-t-r 1- dlr-ct-d ~traight down tb- trachea toward the blrrucatlon between th- bronchl B-cau~e Or the normal anatomy or th- bronchl wh-reln th- l-rt bronchu~ 1~ at a 1 32~348 more acute angle to the trachea than the rlght bron~hus, more of the oxygen ~rom that catheter tends to be dlrected into the right bronchus rather than being directed or mixed for more equal utilizatlon by both bronchi Also, as 05 structured, the oxygen can strike the carina, resulting in an undeair~ble tickllng sensation and cough In addition, in such devices, i a ~ubstantlal portlon of the oxygen is directed again~t the back wall of the trachea causing erosion of the ~ucosa in this area which ~ay cause chapping and bleedlng Overall, because Or the llmited output from the device, lt ~ay not operate to ~upply sufficient supple-mental oxygen when the patient i~ exercising or otherwise quite actlve or has severe dlseasa Thus, none of the prior art devices are fully suitable or outpatient use on a long term basis lt i9 therefore an ob~ective of the pre~ent invention to provide a catheter, catheter lnsertion sy~tem and method for cathetsr insertion and use whlch will provide ~or efficient long term oxygen therapy, particularly for active patient~
The pr-sent inv-ntion provides an apparatus for supply-ing suppl-mental oxygen to a patient from a portable supply of oxyg-n which ls capabl- o~ being carried by uch patient, and which oxygen is cap~bl- o~ being introduc-d unitormly into both of the lung- of uch patient on a oontinuous long t-r~ d~lly ba-l~ by conduction of upple~ental oxygen into th- corvic~l trach-a (below the crlcold and abo~- th~
~t-rn~l notch) through ~ tran~tracheal tube ~eans unit includlng an intratracheal catheter portlon dl~pos-d in the -6- ~ ~ 2 ~ 3 ~ P, trachea ln a downwardly extendlng poaitlon ln tbe trachea with a distal end portion Or such catheter, structured and located in the trachea suf~lciently remote rrOm the cricoid to permlt adequate mixing o~ the oxygen introduced with the 05 air from a ~pontaneously breathing patient In one torm of the lnventlon, the transtracheal tube means unlt comprises one contlnuous length of tublng, and ln another presently preferred form comprises a 6eparate lntratracheal catheter member and a separate external oxygen supply tube member ~he lntratracheal catheter apparatu~ comprises an elongated flexible tube means having a durometer Or ~rom about 70 to about 90 Shore A and a length suf~icient to locate the dlstal end portlon inwardly within the trachea of the person above the carina; and to locate a proximate end portion outwardly o~ the neck ~or attachment Or the proxlmate end portlon to a tube connected to a portable supply of oxygen carrled by the person~ the lntratracheal tube means having a lumen having a contlnuou~ ~mooth cyllndrical outer peripher-al sur~ace and a continuous smooth con3tant diameter lnner periph-ral ~ur~ace de~ining an elongated contlnuous cylln-drlcal pa-~ag- o~ constant outsld- dlam-ter o~ between approxlmat-ly 1 8 to 3 5 mllllmet-rs and belng made o~ a rl-xlbl- grade polym-rlc mat-rlal havlng an ln~ld- dlameter o~ b-tw--n 1 7 and 3 0 mllllm-t-r-t and oxygen outlet op-nlng m-an- at the dlstal end portion Or the tubuiar means lncludlng a downwardly and ant-rlorly raclng oval end op-nln~, wh-n ~ald tub- m-ans ls ln plac- ln th- trach-a, ~or~-d by a b-v-led nd ur~ac- ~he dlstal nd portlon o~
ald tub- m-an- may also addltlonally contaln a plurallty Or sid- wall op-nlngs locat-d ln pr-determln-d spaced r-latlon-hip abov- ald nd op-nlng and xt-ndlng through eald -7- l 329348 sidewall and facing ganerally rorwardly toward the anterior portlon of the trachea ~or aupplying oxygen only in a forwardly facing dir3ctlon whereby rearward flow of oxygen toward the posterior portion of the trachea is limited to oS prevent eroslon The tube means may additionally contain reinforcement means ~ounted completely within said sidewall between ~aid outer peripheral surrace and said inner periph-eral surface In one rorm Or the inventlon, the reinforce-ment means extends at lea6t between ~aid proxi~at- end portion and 6aid sidewall openings ~or maintaining a con-stant lumen cross-section in said tube means by resisting restriction of said central passage means in order to maintain said continuous constant diameter of said central pas~age means during oxygen therapy use In the presently lS pref-rred ~or~ o~ the inventlon, the relnforce~-nt mean~ is located in the external oxygen supply tube member The tube neans ~ay also be provided wlth hydrophlllc ooating means on tho portlon whlch reside~ lnslde the trachea and covering the cyllndrlcal outer ~urrace, and the cylindrical lnner 6urrac- and the ~lde and end openlng ur~ac-s for llmiting adh-~lon and ~ubsequent build-up Or mucous-type materlals pre--nt ln th- trachea whlch would otherwise re-trict th-rlow or oxygon through ald tube m-an- ~hu~ the lntra-trach-al cath-t-r, a~ provlou-ly d--cribed, comprl--- a thin, rl-xlbl-, kin~ and collaps- r~ tant, trach-al tub-mean- having a proxlmat- nd and a dlstal end whlch 1-~lxodly attach-d to a rlang-d support means ngageablo wlth the patl-nt n-ck and conn-cted to an external oxygen ~upply tub- m-an- whlch may b- an xterlor portlon Or on- contlnu-ou- length or tublng or a separ~t- outwardly extendlng tube member A releasable connoctor means 18 attach-d to the -8- l 329348 outwardly extending proXinatQ end ot the external tube portion a sufflclent dlstance so as to be capable of belng viewed by the patient, 60 that the patient is better able to connect the external tube portion to a source of oxygen and 05 to facllltate cleanlng the catheter on An out-patlent basls The invention also conte~plates a ~ethod ot inserting a transtracheal catheter ln the trachea of a patlent ~he ~ethod comprlses, under local anesthesia, the steps of lntlltratlng th~ ~oft tlssue overlylng the anter~or slde ot the cervlcal trachea; advanclng a hypoder~lc needle through the anesthetlzed tlssue lnto the trachea; in~ecting local anesthetic lnto the trachea through the needle; lnserting a guide wlre through the needle; re~ovlng the needle over the guide wire; ln~ertlng a tissuo dllator over the gulde wir~
lS to nlarge the tract; r-movlng th- dllator; lns-rtlnq a Stent over the gulde wire hnd through the enlarged tract;
removlng the gulde wlre~ sacurlng the 8tent by approprlate ~eans, ln place tor a tirst perlod of tl~e whlle lnltlal heallng Or th- dllated tract occurs o as to allow 41r to tr--ly pa-- out through th- lu~en ot th- t-rno rather than accu~ulatlnq und-r th- kln wlth the adherent rlsk of ln~ury7 renoving the St-ntt ln~-rtlng a flrst cathet-r ln th- tract, whlch may b- u--d on a temporary or longer-t-r~
ba~l-, and -curlng th- tlrst catheter ln plac- untll the tract co~pl-t-ly heal- Then, th- tlret cath-ter may b-r-~ov-d and a -cond cath-ter ~ay b- ln~-rt-d Thl- unlqu-~-thod allows th- u-- ot a uall n--dl- tor th- ln-~rtlon Or a cath-t-r whloh 18 larg-r than th- n--dle, but stlll capabl- Or provldlng suttlcl-nt uppl-mental oxygen tor oxyg-n therapy wlth actlv- patlent~ and not oo large as to r-qulr- a ~a~or ~urglcal operatlon to lns-rt The tlr~t 9 1 3293~8 catheter is designed to enable cleaning in place by a cleaning rod with sallne ~olution The second catheter is designed to enable cleaning by removal by the patient ~he preferred apparatu~ for carrying out the foregoing os procedure to create the tract can be provided ln the form of a flrst klt Tbe ~lrst klt pre~erably lncludes a hypodermic ne2dle ror tormlng the small tract or 2istula throuqh the trachea and tor use with a syringe tor in~ecting an anes-thetlc lnto the trachea atter the needle 18 ln~erted through the trachea to form the tract The first kit also lncludes a guide wlre for lnsertion through the needle to maintain the tract after the needle is removed A dilator is provid-ed, which i8 tapered and has a central passageway rOr threading it over the guide wire so that it can be used to l~ gradually stretch the tissue to increase the diameter of the tract or openlng A Stent, having a central passageway is al~o provided ln the kit and is inserted in the dilated tract a~ter the dilator 18 removed in order to maintaln the size Or the tract or opening to tacllltate lnitlal heallng o th- tract Th- guide wire i~ th-n r-mov-d Th- Stent is held ln posltlon durlng heallng by ~uturlng A second kit or pacXage includ-s the tirst cathster which has a singl- openlng at a beveled distal end and replac-s th- Stent Th- beveled end on the flrst c~thet-r le long-r on the po-terlor slde 80 that the oxygen stream ls dlr-cted away tro~ th- ~uco~a and toward the center ot the trach-a Thl- ~lr-t cath-t-r remaln- ln plac- untll the heallng 1- conplet- and c~n be connected to a supply Or oxyg-n durlng thl- p-rlod A ol-~nlng rod 1~ al-o lncluded ln th- ~-cond Xlt whlch 1- used perlodlcally to clean out mucou- whlch ~ay torm ln th- dl~tal nd ot th- cath-t-r To -lo- 1 3~934~
facllitate dlsconnectlng and reconnectlng the oxy~en supply and the cleanlng o~ the catheter, the proximate end o~ the catheter extends a 8U flClRnt dlstance outwardly from the surface of the tissue and the catheter holder ~o that the 05 patlent can see the connector thereon over hls chln Flnally, a thlrd kit or package lncludes a renovable, second catheter which has ~imilar dl~enslons as the rirSt catheter and replaces the fir~t catheter at the end of the tract healing perlod The second catheter ha~ a tapered d$stal nd llke th- t-~porary catheter and also has a series of spaced openlngs in the anterior slde wall thereo~ to ~acili-tate ~lxing o~ the oxygen supplied through the tube with the air inhaled by the patient These openings are spaced about an arc which does not exceed 60 fro~ the mid-llna on the anterior slde of the tube The klts which have been described, together with the unlque rirSt and ~econd cath-t-rs, provlde the m-ans ~or installing the catheter~ by a unigue nethod The catheters are suitable for out-patient u~e over extended p-riods Or tln- by patients ~urfering rrO~ lung diseas-- causlng hypoxla The catheters can be cleaned by th- patlents, th-s-cond cathet-r b-lng r-~ovabl- by th- patlent rOr cleaning and r-ins-rtlon 8-cause of the external xtension of the proximat- nd Or the tube beyond the conn-cting flange of th- dl-clo--d fast-ning ~-an-, the patl-nt can ~- the conn-ctor and a-ily ~anipulat- lt to conn-ct and dl~conn-ct th- oxyg-n and ln-tlll drugD or other u-dlcatlon~
Addltlonal advantag-- o~ the lnv-ntlon wlll b-come appar-nt frou th- d-~crlptlon whlch follow-, tak-n ln con~unctlon wlth th- accompanylng drawings ~ 3~934~

Flg l i6 a perspectlve vlew showlng the transtracheal catheter of this invention mounted through the skin and into the trachea of a patient and showlng the oxygen supply connecting tube secured to the patlent's wearlng apparel between the connectlon to the transtracheal catheter and the connector to a supply Or oxygen;
Fig 2 i~ a diagrammatical lllustration o~ the ln~
tratlon Or a local anasthetlc lnto the trachea by mean~ o~ a needle on a syrlnge;
Flg 3 ls a dlagrammatlcal lllustr2tlon o~ the ln-sertlon of a guide wire through the needle after the syringe is removed;
Fig 4 is a dlagrammatical lllustratlon o the in-sertion o~ a tlssue dllator over the guide wlre a~ter the needle ls removed Flg 5 15 a diagrammatlcal lllustratlon o~ the in-sertlon o~ the Stent arter the dilator and the gulde wlre have been removed Flg 6 ls a dlagra~matlcal lllustratlon Or the ln-8ertlon o~ a flrst transtracheal catheter a~ter removal Or th- St-ntJ
Flg 7 1- a dlagrammatical illu~tratlon Or th- in-sertion Or a ~econd catheter, arter removal Or th- rlr~t cathet-r~
Fig 8 i- a dlagramm-tlc vl-w o~ th- trach-a with a tlu-h-uount-d prlor art oath-ter ~howing th- ori-ntatlon Or th- cath-t-r and th- flow of oxygen to the patient rrom the cath-t-rJ

-12- 1 32~3~8 Fig 9 ls a diagrammatlc view of the trachea, ~lmilar to Flg 8, but showlng the thorough mixing of oxygen and air by means of the catheter of thls lnvention;
Fig 10 ls a side elevatlon o gulde wire which forms a os part of a ~lrst kit of thi~ inventlon;
Fig 11 is a slde elevatlon of the dilator, which ~orms a part of the flrst klt of this lnventlon, for use ln the method Or implantlng the transtracheal catheter of this invention;
Fig 12 iB an end vlew oS the dlstal end of the dllator of Fig 11;
Flg 13 i5 a side elevatlon of a Stent which forms a part o~ the flrst klt of thls invention;
Flg 14 ls a side elevatlon of a cleaning rod which for~s a part of a second kit of this invention;
Fig 15 i9 a side elevatlon of a flrst catheter which forms a part Or the second kit o~ thi~ invention;
Flg 16 1~ a ~lde levation Or a removable, second catheter which ror~s a part of thls invention;
Fig 17 1- an nlarged vertical section, tak-n along lin- 17-17 Or Fig 16, showing th- ~ngular spacing Or the openlngs;
Fig 18 1- an nlarged v-rtlcal -ctlon, tak-n along lln- 18-18 o~ Flg 16 ~howing th- r-inrorcing m-an- withln th- tublngt Flg 19 1- an nlarg-d v-rtical ection, tak-n along lin- 19-19 of Flg 16 howing an attacho-nt m-ans ~or th-transtrach-al catheterJ
Flg 20 1- a graph co~parlng oxygen th-rapy by an analy-l- o~ blood oxyg-n durlng ex-rclse o~ th- catheter of th- pre--nt lnv-ntlon compar-d to oth-r therapl--~

-13- 1 3293~
Fig. 21 ls a perspective vlew of a presently pre erred embodiment o~ the sy6tem, including a transtracheal unit and an oxygen supply hose unit in use with a patient;
Fig. 22 is a longitudinal cross-sectional view of the 05 transtracheal unlt shown ln Fig. 1 prior to insertion into the trachea;
Flg. 23 1B a tran~verse cross-se^tlonal view o~ the transtracheal unit o~ Flg. 22 taken along line 23-23;
Flg. 24 16 an enlarged longitudinal cros---octional view of th~ oxternal reinforced tube member of the trans-tracheal unit o~ Flg. 22;
F~g. 25 is a side elevational view partly ln cross-section o a Stent;
Fig. 26 i~ an end vlow o~ the Stent of Fig. 25;
Fig. 27 is a longitudinal cross-6ectional view of the connector ~emb-r of the tran~tracheal unit of Fig. 22;
Flg. 28 ls an end view of the connector member Or Flg.

2~;
Fig. 29 is a longltudlnal sld- elevatlonal view of the oxygen tanX connector ~erber for th- oxyg-n supply hoso unit shown ln Fig. 1~
Flg. 30 1~ a longltudlnal cross-sectlonal vlew or the connectlon ~-nber o~ Flg. 29;
Fig. 31 1~ a ld- l-vatlon~l vl-w Or th~ tran-trach-al unlt conn-ctor ~-~b-r for tho oxyg-n upply ho~- unlt Or Flg. 1~ and ~ lg~. 32 ~ 33 ~how a cl-anlng rod.

-14- 1 ;~293a ~3 A8 best seen in Fig 1, a patient P has been ~itted with a transtracheal catheter C In one torm o~ the lnven-tion, the catheter includes a flexible tube lo having a beveled distal end opening and may have a plurality of side 05 wall openings 12 at the distal end thereof which havs a specific orientation to facilitate the ~ixing o~ the oxygen with the alr being breathed by the patient, a~ ~ore fully explain-d her-inaft-r The dlstal end, which extends through a tract in the trachea 14, is positionQd above the carina 15 to supply the oxygen to the right and le~t bronchus 16 and 17 The catheter i9 inserted into the cerv~cal trachea, in a manner more rully described hereinaf-ter After insertion, attachment reans 18 is used to secure the catheter C to the patient's neck by neans o~ a chain 20 extendlng around the patient's neck The proxlnate end o~ catheter C extends away ~ro~ the patient'~ body and has a connector 24 attached to tube 10 through whlch oxygen 1- upplied to the patlent As is readily apparent, the extension provided, nakes it possible ~or the patlent to see connector 24 over hl~ chln so as to connect and disconnact the oxygen ~upply tube and to even renove the catheter, ~s an outpatient, at ho~e, for cleaning and then replac- lt and reconnect the oxyg-n supply The sourc- o~ oxyg-n can b- ~ro~ any sourcQ o~ oxyg-n uch a~
pressuriz-d oxygen t~nk~, liquid oxygen reservoirs or oxygen concentrators, wlth soue varlatlon ln the prescribed rlow rat--As shown ln Flg 1, an lntermedlate reln~orced tube 261- provit-d whlch 1- conn-ct-d betw--n conn-ctor 24 through cllp 30 whlch 1- shown on a narrow b-lt 32 that can b- worn underneath th- cloth-~ Or the patl-nt P How-v-r, the cllp -15- 1 3293~8 30 can be attached directly to the patlent's wearlng apparel instead o~ u31ng A ~upplemental b~lt Th~ connector 34 1~
then connect~d to tube 36 to oxygen ~upply 38 The purpose o~ this tructure is to assure that as the patient moves o5 about, the patient wlll not move to the linlt o~ the tubing and place a stress on catheter C which could pull the cath~ter out o~ the trachea and perhaps cause in~ury or disco~fort to the patient With the inter~ediate tubing arrange~ent as shown, any tension would be placed on tube 36 and not on tube 26 In addition, the connector 24 is designed to disengage this al80 when sub~ected to a 1 - 3 pound pull The catheter syste~ of the present invention ~ay include two catheters The fir~t i5 ~ometime~ referred to herein as a te~porary catheter which is used for a li~ited period o~ tl~e whlle the tract or ~istula ~or~ed through the trachea heals The ~econd catheter ls ~o~eti~es referred to as the rinal catheter which iB capable o~ being used by the patient on a long t-r~ basi~ but can be removed by the patlent, at home, rOr cleaning on a periodlc ba~ls ~owev-er, lt will be under~tood that the ~irst catheter ~ay also be u9-d on ~ long-term basis without use Or the second cath-t-r ~h- dirrer-nc-s in th-se cathet-r~ wlll b- 20re rully xplaln-d b-r-inarter Both catheters ar- ~ad- Or the am- nat-rl~l and~ wlth o~- dlrr-r-nc--, hav- th- a~e dlu-n~ion~ In thl~ r-gard, rOr an adult pati-nt, th-cath-t-r will hav- a l-ngth Or approxlust-ly 20 c~ and b-mad- Or polyur-than- havlng a duro~eter b-tween about 70 and about 90 8hor- A (8hor- 80A b-lng pr---ntly prer-rr-d) and a r-latlvely ~mall outsld- dia~et-r (- g , approxi~at-ly b-tw--n 1 ~ and about 3 5 milllneter-) uch a~ to occupy -16- 1 ~293~
only a small portlon o~ the trachea wlthout lmpedlng normal spo~t~neou~ breathing o~ the patient The attachment means 18 ls located near the midpoint of the tube a~ter placement and ls approxlmately 7 to 11 cm (preferably 9 cm) from oS connector 24 on the proximate end of tho tube and approxi-mately g to 13 cm (pre~erably 11 cm) rrom the distal end of the tube when in place in the trachea For an adult, the preferred di~mcter iB an a or g French catheter In 60me instances, it is contemplated that the outside diameter might be as small as 1 8 rm O D It ls also contemplated that for pediatric patlents the diameter might be as small as 1 5 to 2 0 m~ o D o~ course, the length would be correspondingly shorter to prevent tbe problems previously discussed The method o~ in~erting transtracheal catheter C i~
best lllustrated ln Flgs 2-7 Convenlently, the method can be carrled out by uslng apparatus contained in three klts The rlr-t klt contaln~ a hypodermlc needle, a gulde wire, a dllator and a Stent The ~econd klt contalns the temporary cathet-r and a cl-anlng rod A rlnal catheter and a clean-ing rod ar- contaln-d ln th- thlrd klt In Flg 2, a loc~l an--thetlc 1~ ln~act-d lnto th- ort tl-~ue- ov-rlylng the cervlcal trach-a by ~-an- o~ a hypodermlc needl- 40 attach-d to a yrlng- 41 contalnlng the an-~th-tlc Typlcally, a 5 cc yrlng- l- rlll-d wlth 1% lldocaln- and plnephrln- at a ~tr-ngth o~ 1 100,000 The ne-dl- ~ay b- 27 gauge x 1 25 lnch--Arter local ane~the-la ls achleved ln tho skln, a No 15 ~calpel 1~ u--d to cut ~u~t th- kln An 16 gaug- thln t 3293~8 wall needle, whlch is ln the ~irot klt, i9 attached to the syringe with the remainder of the anesthetic solution, and the needle i9 advanced into the trachea Proper position may be documented by drawing back on the syringe and getting 05 a return o~ air bubbles in the syringe The re~ainder o~
the aneathetic i8 then deposited in the trachea Because o~
the small size o~ the needle, the possibility o~ hemor-rhaging io greatly reduced even though the tissue being penetrated is vascular A 32 cn otralght guide wire 42 io passed through the 18 gauge thin wall needle 40 into the trachea as oeen in Fig 3 The bevel on the needle and angle of insertion are exploited to direct the guide wire downwardly into the trachea Conveniently, indicia, such as a notch is provided on the base Or the needle to indlcate the orientation o~ the bevel The noedle 40 is then reuoved over the guide wire A~ be~t s-en in Fig lO, guide wire 42 has an atrauma-tic end 43 which ls d-signed not to ocratch or otherwise in~ure the mucosa or trachea when the wire io inserted This atraumatlc end i- prererably about 5 cm long Th- wire lnclud-- a c-ntr~l longltudinal wlr- rormlnq a core and a splrally wound wlre around the core wire which core wire ext-nd~ b-yond on- end or the oplral wlnding- oo ao to rorm th- rl-xibl- atraumatlc end Th- gulde wlre has a reSerence uark at about 11 cm rrOm the atrau~atlc nd to advl-- th-phy~lolan on depth Or lnsertion N-xt, pr-rerably a lO Fr-nch by lS cn long Terlon dllator D, round in th- rlr~t ~lt, havlng a central bore 46 ln the body 47 1- p~s-ed over th- gulde wlre 42 lnto the trach-a ~h- lnltlal mall tract or rlstula cr-ated by the hypod-rmlc n--dl- 40 1- g-n-rally nlarg-d by th- ln~-rtlon -18- 1 32934~
of the taper of diotal end 45 of the dilator into the tract As the dilator is inserted no ~urther than mark 48, see Fig 11, the tract 15 stretched without cutting until it i~
enlarged su~ficlently to receive the Stent The tapered end oS 45 is pre~erably about 12 rm long The dilator re~ain~ ln place ~or at about one ~inute to ~ccomplish su~icient stretchlng o~ the tissue Next the dllator is re~oved with the wire remaining in place and the St-nt S i~ pa~sed through the tr~ct lnto the trach-a ov-r th- wlre, a~ best ~een in Fig 5 The ~truc-ture Or Stent S i5 illustrated in Flgs 13 The flange serves to stabilize the Stent by sutures placed through its eyelets and adapts to conventlonal ~uer taper connector~ ~or lnstallatlon Or lidocalne to ~uppress lS coughlng The Stent h~ ~ body 51 whlch is ~de o~ ~uffi-ciently rigid nat-rial to hold the tract which has been for~ed ln the trachQa open This Stent body 51 ha~, prer-erably, a 9 French diameter and iB prererably about 11 c~
long rom the dlstal tapered nd 52 to the proxi~l end 50 ~he tapered end 52 racilitate~ in~ertion o~ Stent S through the tract ln the trachea A pass~geway 53 extends through the St-nt to allow ~lr to pa~ out without golng under the skin to uini~lz- the d~nger o~ the patient exp-riencing subcutaneou~ mphy~-~a, during the proc-~s Att-r typically on- w-ek, or longer i~ lndicated, Stent S lo r-nov~d by the phyolclan and a te~porary cathet-r T is lno-rt-d, ~e !hown ln Flg 6 On- ~oru o~ tructur- o this cath-t-r 1~ beot o--n by r-~-renc- to Fig 16 Th- t-npo-rary oath-t-r 1- long-r than th- 8t-nt, b-lng about 20 o~ ln l-ngth ln ~act, th- l-ngth o~ th- dl~tal nd 54 tenporary cath-t-r T Whlch re-to lnold- th- trach-a 1~ ~pproxi~ately -19- 1 3293~
ll cm long, which ls the ~ame length as the distal end of the S_ent The temporary catheter has a conn0ctor 56 at the proxlmate end 58 thsreor ror attAchment to ~n oxygen supply The extra length provlded by proxlmate end 58 makes it oS possible for the patlent to see connector 56 ~o th~t he c~n easily connect or dlsconnect the oxygen supply and can clean the catheter, as descrlbed below Thls ~orm of the catheter also has a longitudinal passagQWay 60 extendlng it6 entire length and may be provided with rein~orclng means 61 wbich may take any rorm, but is illustrated a9 being in the form of a helical wlre embedded within the tubular ~aterlal that forms proximate end 58 and distal end 54 of temporary catheter T The purpo~e of this armoring is to reduce the pos~ibillty o~ the catheter collapsing, or kinking from any manlpulatlon done by the patlent to thereby help assure a constant supply Or oxygen to the patlent by keeping a constant cro~s-sectional ar0a in the catheter lumen This is lmportant lnce this device will be used by an outpatlent who wlll not be under constant medlcal supervision The di-tal nd Or low-r portlon S4 ha- a taper 62 whlch i9 longer on th- post-rior side to racilitate ins-rtion and also to de~l-ct the oxygen lntroduced through the catheter away rrom th- ~ucosn at the back Or the throat and to dlrect th- oxyg-n downwardly and allghtly rorwardly Arter proper po~ltlonlng th- to~porary cath-t-r T 1- connoct-d to a ourc- Or oxyg-n Th- oxyg-n rlow 1- th-n ad~u~t-d to achi-v- a blood oxyg-n eaturatlon Or ~t lea-t 90~ by ar oxlm-try or art-rl~l blood ga~ analy~l-81nc- oxyg-n 1- now b-lng uppll-d to th- patl-nt through t-mporary cath-t-r T, lt 1- n-c--ssry to ke-p pa--ag-way or lu~-n 60 op-n Thl- 1- accompll-h-d by u-- Or -20- 1 3293~8 a cleaning rod, such as cleanlng rod R o~ Flg 15 Thls form of cleaning rod 18 conveniently made Or a rlexible plastic and lncludes a long ~haft 64 which terminates at its upper end ln a handle 66 formed as a right angle extension oS from the shaft 64 Shart 64 is slightly longer than the total length Or the temporary catheter T To clean out the catheter, the oxygen i~ dlsconnected and a saline solution is instilled through the passage, and then shart 64 Or cleaning rod R i8 ins-rted through connector 56 and along passageway 60 ~ecau~e o~ the sizlng, the length o~ chaft 64 is ~urrlcient to completely expel any mucous whlch has accumulated withln the passageway Also, the diameter of shaft 64 i5 ~ust slightly less than the inside diameter of passageway 58 This cleaning is normally done twice a day, or as often as needed After cleaning, the cleaning rod R
is removed and the connector 56 is reconnected to oxygen supply The temporary catheter is prererably kept in place rOr ~ix we-ks or longer ~o that the tract or rlstula through the trach-a can h-al compl-t-ly Art-r compl-t~ h-aling has occurred, th- phy-ician remove- the t-mporary cath-t-r T and provid-- th- patl-nt wlth a rlnal cath-t-r C whlch 18 lns-rt-d and po~ltion-d a~ shown ln Fig 7 Thls catheter 1- lmllar to the temporary cath-t-r T with certaln dirf-r-enc-~, a~ num-rat-d below Th- tructur- Or on- rbodl~-nt o~ th- ~lnal tran~-trach-al cath-t-r C, whlch 1- ~ part Or th- thlrd kit, 18 shown ln Flg- 16-19 The upp-r or proxlmate portlon 68 Or the cath-ter tub- 10, as well a~ th- lower portlon 70, 1-1 3~934g also reinforcad by meane ~uch as a coll prlng 72 which ls partially ~hown dlagrammatlcally a~ e~bedded ln the tubing (see Fig 18) The purpose of this armoring ls also intend-ed to reduce the possibility of collapse or kinking of the 05 tranetracheal catheter whlch could reetrlct the oxygen supply to the patient Conveniently, coil spring 72 extends a fiufflclent dlstance along the length of tube 10 to provlde the descrlbed features with flange or rastening ~eans 18 located at about 9 cm ~rom the proxlmate connector 24 and about 11 cm from the distal tip Each ~ide Or the fastening means has an aperture 74 (Flg 19) for receiving a chain 20, or other holding means The catheter tube lo is provided with a longltudinal passageway or luoen 76 and the dlstal end has a taper 78 wlth a longer posterlor side ~or dlrect-ing the oxygen away from the ~ucosa of the trachea Aplurality of openlngs 12 are spaced about the anterlor slde Or th- cathet-r through an arc o2 approxlmately 120 and are all positloned on the portlon of the ldewall which faces lnwardly from the back wall o~ tha trachea and are located abov- the ~horter nd of bevel 78' In other words, the openlnqs ar- spaced wlthln 60 to elther sld- o~ a mld-line 80 on th- anterior lde of th- tub- 10, a- ~hown ln Flg 18 ~ h- dlstlnct advantage o~ thls arrang-ment will be appar-nt ~rom a vi-wing o~ Flgs 8 snd 9 In Flg 8, a prlor art cathet-r X 1- hown havlng a tubular body ~-mber 82 wlth a flat di-tal nd 84 and no openlng- ln th- sld--wall A- can b~ n, most of th- oxyg-n 1- dlr-ct-d tralght downwardly ln a tr-an lnto the right ~aln str-am bronohu- 16 lno- it xtend- on a ~or- tralght downwardly path fro~ th- trachea than do-~ the l-ft bronchu- 17 ~g a result, alr b-~ng drawn lnto th- lung- or the patl-nt by -22- 1 3293~(3 normal breathin~, as shown by arrows 86, wlll be less llkely to e~fectively mix with the stream o~ oxygen ~rom the distal end 84 of catheter X as shown by arrows 88 on the other hand, in one embodiment shown in Fig 9, 05 oxygen is dl~charged ~rom catheter C through the beveled or tapered dlstal end 78 snd openlngs 12 ~o a~ to be directed away ~rom the mucosa at the back wall o~ the trachea and out lnto the body o~ the trachea ag lllustrAted by arrows 9O to promote better mixing with the air rrom thQ patient' 5 natural breathing, as indicated by arrows 92 This will occur because the oxygen is issued in ~ulti-directional streamg 80 that a su~stantial equal amount o~ oxygen en-riched air passes essentially unifor~ly into both the right bronchus 16 and the left bronchus 17 and minimizes the lS drying effect of oxygen on the mucous membranes Another i~portant distinction between the prior art cathet~r X and cath-ter C 18 that th- conn-ctor o~ catheter K is ~lush against the trachea whereas the proximate end or extension 68 o~ catheter C extends outwardly ~or about g cm Thls ma~es catheter C sultabl- rOr outpatient use, whereas catheter X i~ not With extenslon 68, the patlent can see connector 24 o~-r his chin so that he can connect and disconnect the oxygen eupply easlly and can perlodlcally remove th- catheter ~or cleanlng Oxyg-n 1- d-llv-r~d at very low pressur~ uch a-below 2 psl and at low ~low rates, whlch ar- usually SO% or l-s- than that which i- r-qulr-d wlth a cannula or cour~-, th- cath-ter ls only ~or us- by a pontan-ously breathlng outpatl-nt Indlvlduals who r-gulr- uor- than 3 llt-rs per mlnut- transtracheal catheter elther at rest or durlng exerol-- can r-c-lv- up to 6 - 8 l/nln wlth th- cat~-t-r o~

-23- 1 3293~
the present inventions It can be ~Qsn from thls chart that ~ith the same ~low rates ln llters per mlnute for the 16 gauge catheter and the catheter o~ the present inventlon, blood oxygenation is improved for the described device The 05 nasal cannulae is clearly not as effectlve as the trans-tracheal catheters o~ the present lnventlon even i~ operated at hlgher flow rates Thus, a substantlal savings can be obtalned rom reduced oxygen use whlle provldlng actlve patient~ with better blood qas values during the therapy Used on a long term basi6, this dlfference ln efflclency should produce even more advantages to the patlent ln both the quality of life and extension of useful life From the foregoing, the advantages of this invention are readily apparent A transtracheal catheter has been provided whlch ls safe and comfortable for a spontaneously breathlng patlent and can be installed in a doctor' 9 office on an outpatient basis wlthout requlrlng hospltallzation A
method o~ installatlon is provided whereby the transtracheal Gatheter i8 insert-d under a local anesthetic, with the patient renalnlng ambulatory all tlme~ ~ecau-- of lts small slze, lnsertlon can be accompllshed with no risk of severlng an art-ry The transtracheal catheter 18 armored so that the po~lblllty o~ klnklng and crushlng 1~ minlmized to assur- a contlnuou~ supply Or oxygen to th- patlent 2S Dl-connoctlon and roconn-ctlon o~ the oxygen supply 1~
facllltat-d The ¢onstant flow of low pre-~ure oxygen lnto th- collap-ed alrway- of emphy~ a patlent- h-lps hold th-bronchlal tub-- open to lmprove th- functlon o~ tho lungs and roduc- th- work o~ breathlng , 24 1 3293~
~ he above-descrlbed method 1~ aecompll~hed by the use of devlees which are prov~ded in a ~irst, second and third kit The first kit includes a needle for forming the initial tract in the trachea; an atraumatic guide wire which 05 is red through the needle to maintaln the tract a~ter the needle is removed, a dllator slipped over the guide wire and used to enlarge the tract and a Stent to replace the dilator to permit the tract to heal A second kit ls provided whieh ineludes a temporary catheter whieh replaee~
the Stent and remains in plaee ror a perlod o~ ssveral weeks whlle heallng o~ the tract ls completed; a cleanlng rod for cleaning the temporary eatheter; the third klt includes a removable, final catheter which replaces the temporary catheter after the healing i8 complete; and a cleanlng rod An important feature o~ this method i~ that it allows a small cathet-r to be inserted by using an even ~mallQr needl- to form a tract which i8 aubs-guently dllat-d The prlor art, on the other hand, requlres elther a large tract ~or a smaller catheter or z large tract ~or a large eatheter or traeheoto~y tub- to resuseltat- a non-breathlng patlent The first Xit is an Ins-rtion Tray that provlde~ all th- aupplies leas at-rll- gloves, Xylicain-, and ~acial tlssu- n-eea-ary to er-at- a traet rOr the transtrach-al eath-t-r- o~ th- pr---nt inv-ntlon Th- pap-r drap- around th- tray ~ay b- op-n-d to s-rv- aa a ~ayo tand eover Th-In--rtlon Tray has two tl-r- The upp-r pr-paratory Ti-r should b- u--d el-an and provid-- th- uppli-- ror punctur-sit~ etlon, loeal an-sthesla and kln pr-paration ~h-Low-r and -~ond Pro¢-dur- Tl-r hould be u~ed sterlle and provide~ th- suppll-s to ereat- a eath-ter traet and stabl-llz- th- 8t-ntlng d-vle--25- 1 3293~g Th~ upper tler will pre~erably contain a surgical marking pen; 2 - 20" lengths of y3 stalnless steel bead chain with connectors; disposable wire cutter; 3 - alcohol prep pads; 5cc Luer tlp syringe; 27 ga x 1.25" naedle; 21 ga o5 x 1.5" needle; Hlblclens soap pacXet; prep well and ~ponge stlck: and 2 - 4x4" gAuze 8ponge~ to dry ~kin.
The lower tier will pre~erably contain a Steri-Drape ~lOlO); 2 - 4x4" gauze ~ponges; #15 Bard-Parker scalpel blade on disposable plastic handle; 18 gauge x 7cm thinwall needle; 5cc Luer tip syringe; 32 cm x .03a" stralght guide wire marked at llcm: 10 French x lS cm tissue dllator ~arked at 8cm; Luba2ax packet; 9 French Stent; Dlsposable needle holder and Dlsposable scissor; 3-0 Nylon ~uturs 2cm on FS-l needle.
The In~ertion Tray there2Ore provides all the supplies less sterlle gloves and faclal tl~sue necessary to create a tract for the transtracheal catheters. Most Or the items lncluded ln the tray are co~erclally avallable and are gathered ln an orderly sequence ~or the convanlence Or the phyBlclan.

MANUFACTURERS OF INSERTION ~RAY COMPONENTS
Surgical ~arking Pen Devon Industries Chatsworth, CA 91311 Stainless Steel bead chain ~cMaster-Carr 05 Chieago, IL 60680 Scissor to cut bead chain American Hospital Supply #32048-022 MeGaw Park, IL 60085 Alcohol Prep pads The Kendall Company Ho~pital Products Boston, MA 02101 5cc Luer taper syrlnge American Pharmaseal prefilled with 2~ Xylocaine Laboratorles with epinephrine 1 100,000 Glendale, CA 91209 Monoject 2~ga x 1 25" needle Sherwood Medical St Louis, MO 63103 Monoject 2lga x 1 5" needle Sherwood Medleal St LouiJ, MO 63103 Hibiclen~ Soap Stuart Pharmaceuticals Wllmington, DE
Sponge 6ticks Johnson & Johnson New Brun~wick, NJ 08903 4x4" gauze sponges Johnson ~ Johnson New Brunswick, NJ 08903 Steri-Drape ~1010 Surgical Produet~
Divi~ion/3M
St Paul, MN 55144 4x4" gauze sponges Johnson & John-on New Brunswick, NJ 08903 #15 Bard-ParXer scalpel ~ecton Dickln~on ~ CO
on disposable handle Lincoln Park, NJ 07035 18~a x 7cm thin wall needle Cook Inc Bloomlngton, IN 47402 5cc Luer taper syringe American Pharmaseal Labs pre~illed with 2ce saline Glendale, CA 91209 Lubafax packet Burroughs Wellcome Co Research Triangle ParX, Web~t-r needl- holder Ameriean Ho~pital Supply t32042-042 MeGaw Park, IL 60085 Suture sel~sor A~erlcan Ho~pltal Supply MeGaw Park, IL 60085 3-0 Nylon ~utur- on FS-l needle Ethicon Inc Som-rvill-, NJ 08876 H-bandag- John-on ~ John-on New ~run~wlek, NJ 08903 Tho remalnlng apparatus 1- eonJtruet-d a~ d--crlbed, wlth bloeompatlbl- mat-rlals where neeessary For xample, th- t-mporary and permanent eathet-r~ are pre~orably eon-truet-d a~ do~erlbod ~rom ~-dieal grade polyur-than- whleh ~ay be eoated as deserlbed wlth a hydrophllle poly~-r ln the ar-a- Whleh ar- xpo--d, ln u~-, to traeheal ~-er-tions The poly~er al~o provldes a lubrlelous sur~aee ~or ease o~
ln--rtlon and r-mov~l ~ho poly~-r, al~o ~lnl~lz-~

-27- 1 ~293~t8 adherence of mucus to the eatheter Such polymers are currently used on other commerclally available medical products such as feeding tubes which are in contact with mueosal sur f aces f or prolonged period6 The PVC material 05 used in the s6curity flange i~ preferably PVC or polyure-thane materlal eommonly used in medic~l devices which are ln contact with the ~kin It is soft and non-irritating PVC
and polyurethane can be securely bonded together The bevel o~ the tip of temporary and permanent eathe-ters, and the ~ide ports of the permanent cathet-r direet oxygen away from the tracheal muco8a toward th- eenter of the air column in the trachea This promotes patlent comfort Proper orientation can be acilitated by employing an a~ymmotric flange on the fastening means (cee Fig 9) Improp-r orientation may affect comfort but doe~ not com-prise efficacy The 9em ext-nsion of tubing from the flange to tho female Luer-type taper eonnector removes the bulk Or the connector- away ~rom th- collar lt ~1BO mak-- manipulation of the eonneetor~ ea~ier ~or the patient In additlon, the 2 pound relea~e (rang- 1-3 pounds) of the female Luer-typ-tap-r eonn-etor 1- a ~-atur- whieh will r-~ult ln a safety di w onn-et rath-r than eathet-r di-lodgement ln the e~ent of an exee-~lv- pull on th- proximal end of the Oxygen Hose Th- Cl-anlng Rod 1- de~lgn-d to remov- d-brl- a- lt 1B
pa~o-d through th- lu~-n Or elther the temporary or p-rma-n-nt eath-t-r Th- l-ngth 1~ preterably S long-r than th-eath-ter, and over-in--rtlon or 10B~ down the eath-ter i-prev-nt-d by th- 2e~ handl- whleh 1~ at a 90 angl- and the snall e~p at th- nd o~ the handl--28- 1 32934~
Both, the temporary and per~anent cath2ter o~ the present invention is mo~t pre~erably an 8 or 9 French reln~orc~d tube made Or medical grade clear polyurethane with nylon coil ~prlng reinforcement and approxlmately 20cm os (7 875") in length Candldztes ~or thls procedure should demon3trate a need ~or ehronie oxygen therapy with arterial blood gasses less than PaO2 55 Torr and an SaO2 o~ le53 than 90% on room air during appropriate medical therapy The use of trans-tracheal oxygen o~fers the patient greater mobillty, im-proved cosmesis, and avoidance o~ nasal irritation by cannulae Patients w~o are inadequately oxygenated with nasal cannulae or 16 guage transtracheal catheters may benefit from better oxygenatlon with the catheter of the present invention The recommended pre-puncture evaluations should identi~y individuais ~or whom transtracheal oxygen therapy i~ eontraindleated and othsrs who reguire ~peclal conJideratlon- ln th- eourso Or tr-atm-nt The Puneture Teehnlque u~es an 18 gauge needle, w~re guide and dilator to streteh an openlng into th- trachea wlth ~inimal dl~eom~ort About one hour be~ore the pune-tur-, th- patl-nt 1~ glv-n is glv-n oral prophylaetle antiblotle wlth a ~ip o~ wat-r I~ not eontralndieated, an oral nareotle 1- al-o adminlst-r-d ~or mlnor sedatlon and eough uppr---lon ~h- patlent remov-- hl- top and put~ on a ho-pltal gown He 1- ~-ated ln a proeedur- ehalr wlth a h-ad r--t, ~nd th- h-ad 1- l-vat-d llghtly to r-produe-the po-ltlon o~ th- n-ek whll- looklng ln a ~irror durlng eathet-r ehang-- Oxygen 1- eontlnued throughout th--29- 1 3 2 q 3 ~(~
procedur~, but cannulae are reposltloned so that they arrlve from bQhlnd the head and do not inter~ere wlth the anterior nec~ T~e Insertlon Tray is removed rrom its plastl~ bag and placed on a Mayo stand at chest level in front o~ the 05 patlent The paper wrapplng 18 opened ~ully to act as a sterlle drape ~or the Mayo stand The super~iclal anatomy o~ the anterlor neck 18 palpated carefully, and the notch of the thyroid cartilage, the cricothyrold membrana and the notch of the manubrlum are marked uslng the surg~cal ~arking pen Vlslble anterlor ~ugular veins ~hould also be mar~ed A ~3 stalnless ~teel bead chaln necklace is then placed around the patlent's neck and trimmed with wire cutters to ~lt ~nugly but stlll accom~odate two flngers The chain is rolled down onto the trapezlus muscles, and the lnt~rsection o the cervical trachea and necklace 1~ marked for aubse-quent puncture The hlghest acceptable puncture should be the tracheal lnterspac- lm~edlately below the crlcoid cartllage (crlcotracheal ligament), and the lowest should be the level o~ the manubrlum occaslonally a less snug necklace will be requlred to reach a low crlcotrach-al puncture slte A second length o~ bead chaln ls lncluded ~or occ~slon- when th- rlrst ls cut too short ~he cus-tomlz-d chaln ls removed and plac-d ln a labeled nvelope ~or later us- The ~ln over the puncture lte 1- prepared wlth an alcohol swab wlthout removlng the orl-ntatlon ~ar~s Th- Scc -yrlnge 19 ~llled wlth 2~ lldocalne wlth pln-phrlne 1 100,000 1- attach-d to th- 27ga x 1 25~ n--dl- At the -l-ct-d lt-, about 2cc o~ thls olutlon 1- lntlltrat-d lnto th- ~ln about 2c~ on lth-r ld- o~ Jld-lln-, and about lcc o~ local an-sth-tic ls deposited lnto deep-r pr-trach-a1 tl--u-- Th- n-edl- 1- th-n xchang-d rOr a -30- l 3~9348 21ga x l~S" needle FaciAl tlssue ls glven to the patient who ls infor~ed of an incipient cough, bad taste and globus sensation caused by the local anesthetic The needle is passed transtracheally at the puncture site, and the remain-os der of local anesthetic quic~ly deposlted onto the tracheal~ucosa A brier paroxys~ of coughlng ~ay result The anterior neck is prepared with Hibiclens soap using a sponge stick Hibiclens 60ap is preferred to v~rious iodophors becau~e it is non~taining and better uited ror this outpa-tient procedure The skin i5 then blotted dry with gauze sothat the procedure drape will ~tlck to the skin The upper Preparatory Tier is now removed from the Mayo stand to expose the lower Procedure Tier which should re~ain sterile Surgical gloves are now put on, and the Steri-Drape is applied to the upper che~t ~t the level o~ the clavicles A lc~ vertical inci~ion centered at the puncture site is ~ade with a ~15 ~calpel Gauz- ponge i~ h-ld ln the palm o~ the other hand while tran-~lxing the trachea to ~alntaln orl-ntatlon Th- lnci-lon ~hould pa~ co~pl-t-ly through the d-rol- lnto ~at ObvlouJ ~nterior ~ugul~r velns should b- avoided The 18 ga needle, attached to the yrlnge contalnlng ~allne, 1~ then dlr-cted through th-lneislon down to the trachea Traeheal cartllage~ are palpat-d, and th- n--dl- 1~ popp-d through an lnter-pac-Alr 1- a-plrat-d lnto th- yrlng- whleh 1- th-n r-uov-d Th- noteh on th- hub o~ th- ne-dle 1~ rotat-d untll lt 1~ on th- low-r rl~, and th- tlp o~ th- n--dl- 1- angl-d downward 45 toward tho carlna Th- atrauratle nd o~ th- wir- gulde hould pa-- ~r--ly lnto th- low-r alrway It 1- do-- not pa~ ea-lly, th- n--dl- should be repo~ltlon-d The needle 1~ wlthdr~wn, and th- llea ~ar~ on th- wlr- guld- 1--31- ~ 3293~t8 positioned at the skin level The 10 French dilator is then tirmly advanced over the wire guide into the trachea but not more than the 8cm After one minute of stretching, the dilator is removed and exchanged for the 9 French Stent o5 Insertion ot the Stent is racllltated by a small amount of water soluble ~elly on its tlp and constant twirling durlng gentle advancement The wlre guide i8 then removed The dlsposable needle holder and scissor are used to suture the Stent to the skln with 3-0 nylon suture Sutures can be placed through each Or 2 eyelets on a ~lange of the Stent taking cars not to close the ~ld-line inclcion The skin and lu~en of the Stent should remain open to minimize the risk er subcutaneous emphysema The H-bandage ls then applied taklng slmilar care not to create an occlusive dressing The patlent 1~ sent to the radiology depart~ent ror postero~nt-rlor and lateral chest X-rays to document cathe-ter pO9 ~ tlon and absence ot pneumothorax and subcutaneous emphysema Nasal oannulae oxygen i5 continued durlng the St-nt wee~, and oxyg-n hould not b- ad~inister~d through the Stent Signl~icant bleedlng ha~ not been observed becau~- th- m-thod 1~ relatlvely atraucatic A nonrunctlon-lng Stent ia lnsert~d ln th- nQwly rormed tract tor one week, and nasal cannulae oxygen 1- contlnued Because the Stent runctlons a8 a draln, bacterlal lnrectlon Or the tract 18 not u-ually ob--r~-d Att-r on- w--k ot St-ntln~, th- t-mpor~ry tran-trach-al cath-t-r 1- lnJerted by the phy-lclan over a wlre gulde, and tran-trach-al oxyg-n th-rapy 1- b-gun ~h- temporary cath-ter 1- do~lgn-d to re~aln ln place durlng th- early weeX- or transtracheal oxygen therapy whén the tract 18 93~

maturing The catheter 18 cleaned in place using the Cleanlng Rod and sterile saline The klnk and crush res~s-tant Oxygen ~ose adapts standard oxygen source~ to the catheter Inadvertent decannulatlon ls protected against by 05 the 6uspender-type eecurity cllp whlch attaches to the top of the pants belt or dress and the 2 pound safety release of the Luer taper connector between the hose and the catheter In sum~ary, the duro~eter value~, i e about 70-so Sbore A, elected rOr the flnal con~lguratlons o~ th-temporary and permanent catheters of the present lnventlonaro de~lrable and lndeed necessary ~or proper lnsertion and long term patient comfort In thls regard, the spacing for the locatlon o~ the holes of the dlstal end of the permanent catheter are preselected, wlthln the range o~ orlentatlon described, to retain a surficient flexiblllty and stlfrness to raollltate proper lnsertlon, removal and cleanlng, ag well as enabllng proper orlentatlon, when ln place, ln order to achleve the benerlt~ descrlb-d hereln An 8 or 9 French size of ths temporary and permanent catheters ls the most prererred slzs slnce tests have hown that the proper back pressure, rOr a preselected range Or oxygen rlow rate- can b- achlQved ror thl- elz- Or catheter to per~lt tho errl-clent utillzatlon o~ supplemental oxygen dsscrlbed hereln .

In a pres-ntly pr-~erred rorm Or ths lnv~ntlon, as shown ln Flg- 21 - 31, a tran~tracheal catheter unlt 100 comprl~-- an lntratrach-al tube ~oans 102, an external oxyg-n ~upply tub- m-an~ 104, a conn-ctor-stablllz-r-support msan- 106 wlth a r-leasabl- oxygen hose connector mean- 108 An oxyg-n ~upply hos- unlt 110 comprl-es a tub- memb-r 111, _33_ 1 329348 a non-releasable connector means 112, a cllp means 113, a tube member 114, a connector means 115 fixedly attached to tube member 111 and a releasable coupllng means 116 flxedly attached to tube mem~er 114 which i5 releasably connectable 05 to ~n oxygen supply ~ource 118; ~uch as a relatlvely small-slze, small-volume (e g 0 6 to 1 1 llters o~ llquld oxygen) llghtweight patlent portable supply tank 117 capable of supplylng 1~2 llter of gaseous oxygen for 10 to 12 hours through convention~l valve rlow control means or ~ relative-19 ly large-slze, large-volume (e g 30 llters Or liquid oxygen), heavy, stand alone-type, maln supply cyllnder or the llXe (not shown) Supply tank 117 may be carried by the patlent ln any suitable bag or pack device 118 having a shoulder or back strap 119 As shown ln Flgs 22 - 24, the lntr~trache~l tube means 102 comprises a continuous one-plece tubular member having an annular passage 120 derined by an annular wall portlon 121 havlng an annular inner peripheral smooth surrace 122 and an annular outer peripheral s~ooth surrac- 123 Dlstal nd portlon 125 has an lnclln-d end urrac- 126 to provld-an oval-shape discharge openlng 127 xtendlng between a low-rmo-t tip portlon 128 and an axially upwardly spaced portlon 129 Tlp portion 128 i5 pr-rerably ~olded and poli-h-d rOr eAse Or in--rtlon, comtort and avo~dance Or mucosal lrrltatlon A plurallty Or rorwardly raclng ld-di-charg- op-nlng- 130 ~ay be provld-d ln sld- wall portlon 121 a- pr-vlouely d--crib-d A locator ~arXlng 131 may b-provld-d on th- upp-r ~ld- wall ~urrac- to prouoe- r-cognl-tlon Or partlal withdrawal ~or r-posltlonlng wlthout com-pl-t- wlthdrawal Proxl~at- nd portlon 132 ha- a rlat -34- 1 32934~
transver~e end sur~ace 133 derlning a cyllndrical inlet opening 134 The intratracheal tube means 102 comprises a continu-ous, one-piece, tubular member made from a length of os straiqht rlaxible thermoplastlc tubular materlal such as polyurethane whlch ea~lly con~orms to the human anatomy to enable ins~rtlon lnto the trachea and has ther~osettlng characterlstlcs 50 as to be able to adopt a flexlble, thermoset, curved ~hape when sub~ect to body temperature in continuous use in the trachea Thus, a portion of the intratracheal tube member will gently rest against the posterior trachea wall in a stable position and will not move over corrugation~ of lateral and anterior tracheal walls wlth noxmal resplratory excurslons whlle stlll maln-tainlng a balance o~ overall flexibillty ~or com~ortIntratracheal tube member 102 has a durometer o~ between approxlmat-ly 70 to 90 Shore A (80 Shore ~ being presently prererred) Tube member 102 ha~ an outside diameter o~
between approxlmately 1 8 mlllimeter- to 3 5 millimeters (3 1 mllllmet-rs b-lng presently pre~-rred~, but may be o~
small-r di~m-t-r (e g 1 5 to 2 7 rm) ~or pedlatrlc pa-tl-nt- ~h- ln-ld~ dlamet-r o~ tub- m-mb-r 102 lo betw--n ~pproxl~at-ly 1 7 to 3 0 ~ (1 9 rm b-lng pr-~-ntly pre-~-rred) o a- to provld- a mlnlmu~ wall thlckn-~- o~ between ~pprox~mat-ly 0 1 to 0 9 mo (0 6n- b-lng pr---ntly pr--~-rr-d) Th- l-ngth o~ tube memb-r 102 ~or adult- ls b-tw--n approxlmat-ly 8cm to 14 cm (11 cm belng pres-ntly pr-~err-d) o that dlstal tip portlon 128 1~ located approx-lmat-ly l to S cm abov th- carlna ln a ma~orlty Or adult p~tl-nts For p-dlatrlc patl-nts, a length o~ 3 to 8 cm may b- ~pproprlat--35- 1 3293~
Connector-6tabllizer-support means 106 ls made of one piece of flexible molded plastic material such as clear PVC
having a durometer of approximately between 51 to 61 Shore A
(preferably s6 Shore A) which compri6es a soft, flexible, os relatlvely thln (e g , approximately 0 72 lnch) flange portion 140 having parallel flat, smooth side surfaces 141, 142 Flat inner surface 141 provides an abutment surface to engage the nec~ 6kin about the lnsertion tract An upper flat peripheral surface 143 1B connected by relatively large radlus curved slde peripheral ~urfaces 144, 145 to inclined lower perlpheral surfaces 146, 147 whlch are connected by a relatively large radlus curved lowermost perlpheral sur~ace 148 An outwardly extendlng hub portlon 150 has a tapered outer peripheral ~urface 151 and terolnates ln a ~lat transverse slde surface 152 A central bore 153 o~ approxi-mately the ~ame dlameter te g , 0 72) as the lnslde dlameter (e g 0 73) of tube member 102, 15 located ln a tran~verse flange portion 154 between counterbores 155, 156 which are preferably tapered and have diameters approximately equal to or lightly le-s than th- outslde dlameters of tube me~bers 102, 104 o a~ to enable lldable, low-friction insertion of th- nd- Or the tub- ~-mb-rs therewithin lnto abutting ngag-m-nt wlth tb- elde ur~aces of ~lang- portion lS4 The nd portlon- of th- tube merb-rs 102, 104 are fixedly s-alably attach-d to ~e~b-r 106 by any uitabl- m-ans uch a- a olv-nt bond whlch i- provld-d by applying a ultable ~olv-nt mat-rlal to th- out-r perlphery o~ ach tubular portlon prlor to ln-ertlon lnto the counterbor-- Whlle lt ls lnt-nd-d that both tub- me~b-rs 102, 104 b- peroan-ntly conn-ct-d to memb-r 106, th- con~tructlon and arrange~ent i~
uch that ln th- v-nt of appllcatlon o~ unu-ually larg--36- I 3~93~
forces (e g 8 to lS pounds~, the bond between tube 104 and member 106 will break before the flange breaks away ~rom the securlty necklace Tube member 102 is precisely oriented relative to flange portlon 140 80 that the oxygen discharge 05 opening in tho tip portlon 128 and slde wall oxygen passag-es 130 wlll be properly located ln the trachea whereby the oxygen ls discharged ~orwardly Flango portlon 140 stabi-lizes the tube member 102, has a low proflle and small sur~ace area and i6 made of so~t mzterial for com~ort and non-lrrltatlon ln use while allowing the skln around the lnsertlon tract ln the neck to breathe Flange portion 140 has clrcular openlng~ 157, 158 for recelving a neck chain or band ~e~ber 158 a6 previously described External tube ~ean~ 104 i8 ~ade of kink and crush-reslstant molded plastlc materlal such as polyurethane relnforced wlth bralded nylon or polypropylene whlch reslsts cracklng and breakinq Pr-~erably, clear plastlc ~aterial is used rOr cosmetlc~ Tube ~eans 104 has a length o~
approximat-ly botween 2 to 12 cm (B cu being presontly pr~-rred) ~o that conn-ctor ~ember lOB is located a sub-stantlal dl~t~nce b-yond the connector-~tablllzer-support ~e~bor 106 to nabl- movement without displac~-nt o~ the intratrach-al tub- u-mb-r 102 and ~or co~ort And easo o~
cleanlng Tub- u-ans 104 has a central cyllndrlcal 6~00th-wall constant dla~eter pa~sage 160 ln an annular wallportlon 161 ha~lng a oylindrlcal p-rlpheral sur~ac- 162 ~rald-d nylon ~at-rlal 163 1- ub-dd-d ln wall portlon 161 End portlon- 165, 166 ar- per~anently ~lxedly attached to ~lang- u-mb-r 106 and conn-ctor ~emb-r lOB, r--poctlv-ly Th- dla~-t-r Or pao-ag- 160 ls approxl2ately th- saue a- tho dlaa-t-r o~ pa--ng- 120 ln tub- m-~b-r 102 and passaq- lS3 _37_ 1 3~934~
in flange portlon 154 o~ member 105 In the presently preferred e~bodiment, tube me~ber 104 has a durometer of approximately 80 Shore A, an outside diameter o~ approxi-mately 3 0 mm and an inslde diameter of approximately 1 7 05 m~
Connector mean~ loB, Flgs 27 ~ 28, is of the same general constructlon as a conventional Luer compatlble tapared oxygen rriction connector devlce and is ~ade o~ a one plece, generally cylindrlcal ~ember 170 made of molded pla~tic ~aterial such as PVC having a durometer Or approxi-mately 51 to 61 Shore A tS6 Shore A being presently pre-ferred) ~ember 170 comprise6 a central rib portion 171 having a central, slightly tapered, generally cylindrical bore 172 extending between enlarged counterbore passaga means 173, 174 ln hub portions 175, 176 Counterbore 173 has a diameter approxlmately equal to the outslde diameter o~ external tube me~b-r 104 and ha- a slightly outwardly tapered ~urface 177 80 ag to enabl- tube end portion 166 to be lldably in-erted into engagement wlth annular ~lde ~ur~ac- 178 ot rlb portlon 171 and then perman-ntly connect-ed to conn-ctor 108 by ultable ~ean~ uch as a solvent bond a- pr-vlou-ly d--crlbed Pa~sage m-ans 174 comprlses a central taper-d conical passage portlon 179 whlch termlnates at radlal ehoulder portlon 180 o~ rlb portlon 171 and an out-r tapered conlcal pa~age portlon 181 havlng clrcum-~er-ntlal opace groove and rib portlon~ 182, 183 R-lea--tab~ 185 ar- provld-d around tran-r-r nd ~urrac- 187 Conn-ctor m an- llS, Flg 31, coaprl~-- a one plec- connec-tor m- b-r 189 mad- Or rlgld mold-d pla~tlc ~at-rlal, ~uch a- polycarbonat- or hlgh den~lty PVC, wlth a central cylln-drlcal pa~-ag- 190, a Lu-r-typ- tap-r-d end portlon 191, a -38- ~ 3~93~3 central abutment flange portlon 192, and a rlbbed end port~on 193 ~or ~lxed lnsertlon lnto the end o~ tube member 111 In thls ~anner, the elongated tapered connectlng male portion 191 o~ connecting means 115 on the end portlon of o5 tubular aember 111 1~ ln~ertablo into pa~sage 174 of connec-tor means 108 and ~ecurely releasably held theraln with a retention force o~ approximately 1 to 5 pounds to provide a sarety di~connect mean~ while also enabling usage o~ stan-dard medical device~, ouch as ~yringes and liquld capsules, to apply llquld aedlcatlons or the llke In the present prererred e~bodlment, oxygen ~upply tube me~ber 111 ls made o~ extruded plastlc materlal, 6uch as PVc having a duroaeter Or between 45 to 60 Shore A (50 Shore A
being presently preferred), with an outslde dlameter Or approximately 3jl6 inch and an inside diameter o~ approxi-mately 1/8 lnch and a length o~ approxlmately 20 lnches oxygen ~upply tube aember 114 i5 made o~ extruded plastlc material, ~uch as PVC having a durometer o~ between 65 to 75 Shore A (70 Shore A belng presently pre~erred), with an out-ldo dlaa-ter o~ approxlaatoly 1/4 lnch and an ln~lde dlaa t0r o~ approxlaat-ly 1/8 lnch and length Or about 50 lnch-- Tub- a-abero 111, 114 ar- peraanently connectod by conn-ctor aeab-r 112 by ~olvent bondlng ln allgned countor-bor-~ a~ pr-vlouely d-~crlb-d Tub- a-mb-r- 111, 114 pr-rerably hav- th~ an- ln~ld- dlaa t-r- to prevent back pr---ur- varlanc-~ and hav- dl~-r-nt outsld- dlaa-ter~ ~or maxlnua coa~ort alang th- body o~ th- patl-nt'- ln-lde clothlng and aaxlaua prot-ctlon agaln-t collap-- or klnklng out-ld- Or clothlng worn by th- patl-nt Cllp ae~n~ 113, Flg 21, conprl~ prlng-bla~od op-nabl- and clo-abl-, plvotally-conn-ct-d ~aw a-ab-r- 113J, such as a ~u~pender-type cllp, wlth ~ plastlc loop member 113L ixedly eecured thereto and slidably ad~ustably frlc-tio~ally mounted on tu~e member 114 ad~acent connector 112 ~or attachment to a belt o~ any slze 05 Oxygen tank eonneetor ~ean~ 116, Flgs 29 & 30, eomprlses an elongated body me~ber o~ molded plastle materi-al, sueh as clear PVC having a durometer ot approxlmately 65 to 75 Shore A (70 Shore A being presently preferred), which i8 intQgrally ~lxedly ~olded ~round and bonded to end portion 114E of tub~ me~ber 114 which termin~tes at 114T in abutting engagement with rib portion 194 ad~acent a passage 195 in ~n enlarged end portlon 196 Passage 195 comprises an outwardly tapered eonieal end portion 198, a central cyllndrical portion 199, and an lnwardly tapered eonical end portlon 200 termlnating ln a eireular openlng 201 ln rlb portlon 194 ~nd having a dlameter approximately oqual to the lnslde dianeter of tub- ~e~ber 114 Head portion 196 ha~ a eyllndrie~l nd portion 202 ~nd an annular, out-r rib portlon 204 eonneet-d to an longated tubular portion 205 by ~ eonie~l surt~e- 206 An lnter~-dlat- portion 207 1-provid~d wlth ~ ~erios ot rib and groov- portlon- 208, 209 to nh~ne- tl-xlblllty P~ssag- 195 18 ~d~pt-d to r~ s-~bly r-e-lv- ~n long~t-d rlbb<d ~al- eoupllng portlon 210, Fig 21, on oxyg-n tnnk 117 Th- eon~truetion ~nd ~rr~nge-~-nt Or eonn-etor ~n- 116 i~ sueh ~ to provld- nn lon-g~t-d h~ndl- ~-an- to nnbl- th- u--r to tlr ly grlp the eonn-etor m-on~ durlng eonn-otlon ~nd di-eonn-etion ~ro~ th-oxyg-n upply ~-~n- wlthout ~lnklng ot tube ~ember 114 ~he t~p-r-d pa--ng- 195 ~ollltnt-- eonn-etlon to th- oxyg-n supply ho~- ~nd provid-- ~ redue-d dlamotor tr~n~itlon to th- upply ho-- lnl-t openlng to Jlnl~lz- b~ek pr---ur-1 3293~8 ~40-The enlarged head portion prevents breakage and crac~ing of the wall portion Figs 25 & 26 shows a 9 French Stent device 220 which is generally eimilar to catheter unit portions 102 and 106 oS and compri~e~ a one piece tubular member 221 having a proxlmate end portlon 222 ~ixedly aounted in a one plece support ~ember 224 which has a ~lange portion 225 and a hub portion 226 Tubular me~ber 221 i9 made of ~lex~ble ~olded plastic material euch as polyurethane havlng a durometar of between approximately 70 to 90 Shore A (prererably about 80 Shore A); an outside dlameter o~ about 3 1 ~ an inside diameter o~ about 1 6 mm; and a beveled dietal end ~urface 227 havlng an angle of inclination of about 35 Support member 224 i~ aade from one piece o molded pla~tic ~aterial such as PVC or polyurethane having a durometer Or between approximately 70 to 90 Shore A (preferably about ao Shore A) Bub portlon 226 has a central tapered pas~age 228 in a central rlb portion 229 conn-cted to countarbore portions 230, 231 A proxlmat- ond portion 222 Or tubular menber 221 70 is rixedly aounted in counterbore 230 by olv-nt bonding as pr-viously d-scribed Counterbore portion 231 ha- a lze and tap-red hape to nabl- in~-rtlon or a ~tandard lze syring- Relatlvely ~mall-~ize openings 234, 236 in rlange portlon 22S onabl- euturing to th- patl-nt nec~, but are aall-r than th- chaln dla~et-r to pr~v-nt u-- Or th-~upport chaln 159 wlth St-nt eupport member 224 A pr-~-ntly pr-r-rr-d cath-t-r cl-anlnq rod 240, hown in Flg- 32 ~ 33, conprl--- an 020 lnch dla~-t-r talnle-a t--l wlr- a-ab-r 2~2 havlng a l-ngth Or approxlmat-ly a.o lnche- wlth an nlargad talnles~ ~t--l atraumatlc ~prlng-tyl-t h-ad portlon 244 havlng an out-ld- dlam-t-r -41- 1 3293~
approximately equal to the in~lde diameter o~ the tube An injection ~olded plastic handle member 246, ~lxedly ~ounted on the other end of the wire, comprises a ~lat abutment surface 248 to prevent over-insertion of the wire beyond the 05 tip o~ the catheter; a pair o~ ~lat alde eurraces 250, 251 with indentatlons 252, 253 or gripping; and a rounded ~ide surrace 254 Thu~, the preeently pre~erred embodiment o~ the inven-tlon provide- a tran~tracheal catheter unit 100 having oxyg-n Slow capabillty Or ~rom 0 1 to a liters per ~lnute through an intratracheal tube ember havlng an lnside diameter o~ approxi~ately 1 7 to 3 0 millimeters The intratracheal tube member i~ ade o~ flexible thermoplastic material havlng a durometer Or approximately 70 to 9o Shore A and le capable Or beco~ing set by body temperaturo in a curvod poYitlon corresponding to the individual anatomy of th- patl-nt Thu-, th- poeltion and angle Or the bend i8 variable ror ach individual patient while nabling usage of a cleaning rod within the oxygon pa~sage in the intratrach-eal tube me~ber Tho construction and arrangement 1~ such that the cathetor tip rests against the ~nooth poeterior wall portion Or th- trachea ~o ~ to r-duce coughing whlch might r0~ult rrom locatlon ln th- c-nt-r Or th- trachea or ln contact wlth th- corrugatsd ld- or ant-rlor wall por-tlon~ Or th- trach~a Th- out~ide dlam-ter ls urrlcl-ntly 8~11 to p-r~it unr--trlct-d ~pontaneou- br-athlng around th- oath-t-r Th- cathet-r tlp 1- b-v-l-d and po-ltlv-ly orlent-d by the external conn~ctlng-locatlng rlango ~o that th- long axl- Or th- oval openlng race~ rorwardly to dlrect oxygen away rrOm th- tracheal ~ucosa to protect agaln~t drylng and lrrltatlon Wh-n relatlvely hlgh rlow rate -~2- ' 1 ~ 2 q ~ ~ ~
oxygen (Q.g. 2 to 8 liters per minute) is to be used, tbe sid~ hole~ located near the tlp portion ~urther dlsperse the oxygen in a forward dlrection for com~ort and to mlnimize dryinq The oxygen pas~age iB open to enable usage o~ a 05 cleaning rod The oxygen ~upply hoso~ and oonnector members provide ~or ~arety and ease o~ usage ~he catheter-oxygen supply hose connector member providQs a 1 to 5 pound ~orce sarety disconnect ~eature The stabilizer member is con-nected to the tube member6 in a manner providing an 8 to 14 pound rorce 6arety separatlon ~eature The large connactor member at the end o~ the supply hose means provides an impedance matching feature while also being kink and crush resistant The lnside diameters o~ all tube members and passages ln connectlng member~ are approximately the Bame 30 as to provlde n contlnuous substantlally unrestrlctQd constant passage between the tip portlon o~ the intratrach-eal catheter and the source o~ oxygen In ~ummary, the lnvention comprlses a system ~or provldlng a contlnuous supplemental supply o~ relatively low pres~ure oxygen at a relatively low ~low rate to enhance spontaneous breathlng o~ a per~on having chronlc hypoxemia Th- ~ystem comprls-- an elongated lntratracheal tube ~eans havlng an slongat-d contlnuou~ constant dla~-t-r central pa-eag- m-ans xt-ndlng b-tw--n an oxyg-n lnl-t op-nlng m-ane at a proxlmat~ nd portlon Or th- lntratracheal tube m-ans and an oxyg-n outl-t op-nlng means at a dl~al nd portlon th-r~or ~h- lntratrach-al tub- m-an~ lx-dly p-r an-ntly ~ount-d on an xt-rnal connector--tablllz-r-upport ~-an- rOr ~ountlng on and upport by th- n-ck Or a 3~ p-rson and ln--rtlon lnto the trach-a or the person through a urglcally rorm-d p-r~an-nt ln~-rtlon openlng ln th- ~kln 1 3 ~ 8 of the person located ln the cervical trachea o~ the person The external connector-stabilizer-~ounting means is oriented relatlve to the intratracheal tube means for locatlng the distal end portion and the oxygen outlet opening means in 05 th- trachea below th- cricold cartllage and ln upwardly spaced relation~hlp to the carlna An external tubular means 1- ~lxedly conn-cted to the connector-~tablllzer-support ~eans and ha~ a length such as to provlde a proxl-mate end portlon and oxygen lnlet opening mean~ located a suf~icient di~tance away fro~ the insertion opening in the skin to enable ~lexlble displacement relative to the connector-stabilizer-support means wlthou' causing displace-ment o~ the lntratracheal tubular means The intratracheal tubular means i8 made o~ a continuoue one-plece constant dia~eter ~lexlble elongated lntratracheal tube ~e~b-r having a continuous constant dlameter pas~age extending there-throuqh and being flexlble when inserted into the ~unctional position within the trachea to provide therein an intermedl-ate curved ~lde wall portion 0xtendlng between a proximate end ide wall portlon having ~n unre~tricted lnl-t op-ning th-rein located out~ld- o~ th- neck o~ a patlent and a ub-tantlally tralght low-roo~t dletal ld- wall portion locat-d ln th- trach-a and ext-ndlng downwardly th-r-ln and havlng ~n unr--tr~ct-d dl~tal nd outlet op-nlng locat-d ln upwardly p~c-d r-latlon-hlp to th- bronchlal tub-e o~ th-patl-nt Th- lntratrach-al tub- m- b-r ha- a r-latlv-ly ~nall outeld- dlau-t-r o~ betw--n approxl~at-ly 1 8 to 3 5 o a- to b- ~ub-tantlally 1--- than th- cross-sectlonal ar-a o~ th- patl-nt trach~a wlthout ub-tantlally reduclng th- noroal lz- contlnuous ~pontan-ou~ breathlng pa~age ln th- trach-a to nabl- norual pontan-ou- br-athlng and ha-1 329~8 an lnside dlameter of no more than approximately 1 8 to 3 0 milllmeters and a wall ~tructure and thickness and a durom-eter of between approxlmately 70 to go Shore A such as to prevent collapse, klnking or other deformatlon causlng os restrlctlon of oxygen rlow and to onable continuous fre~
flow of relatlvely low pressure relatively low ~low rate oxygen therethrough trom the inlet openlng to the outlet openlng wlth the pressure of the oxygen being no more than approxi~ately 2 psl w~th tlow rates up to 8 liter~ per minute The connector-stabilizer-support means is connect-abla to neck support means tor mounting around the neck o~
the per~on at a locatlon between the larynx and the sternum and rOr holdlng the connector-~tablllzer-~upport ~eans proximate to the in3ertion opening ln the ~kin A triction-al coupling means i3 provided on a proximate end portion ofth0 external tu~e means tor rel-a~able connection to an oxygen ~upply tub- means which compris-s a ~lrst portion tor aountlng next ad~acent the upper body o~ the person beneath clothing and having a disconnectable coupllng means tor r-loasable frlctlonal coupllng to th- xt-rnal tube moans The oxygen supply tube ~eans turthQr comprise- a second portlon wlth a coupllng m-an- rOr coupling to th- oxyg-n upply ourc-Th- dl-tal nd outl-t op-nlng on the lntratrach-al tube n-mb-r ha- an lnolln-d end sur~ac- and d-tlnea a longltudl-nally xt-ndlng o~al openlng or lot ~eans ln a tront portlon Or th- dl-tal sld- wall portlon whlch 2aco- toward th- ~ront ld- o~ th- trach-a o~ th- patl-nt tor nabllng only downward and torward tlow ot oxyg-n rron tho outl-t op-nlng and ld- taolng lot ~-an- wlthout rearward tlow toward th- r-ar ld- ot th- traoh-a -45-; ~ 32q3~8 A plurallty o~ transverse laterally spaced ~orwardly facing oxygen outlet passage means may be provided ln the distal slde wall portlon in upwardly spaced ~uxtapositlon to the outlet opening and are located on only the 20rward half 05 of th~ dlstal ~lde wall portion facing outwardly toward the front side of the pationt's trachea in a sid~ wall area of no more than 180 circumference for enabling only rorward and downward flow of oxygen toward the front of the trachea through tho alr outlet pas-agQ m~ano wlthout roarward flow toward the rear ~ide of the trachea It ls contemplated that tho lnvontive concepts her-in d-scrlbed ~ay bo variously othorwi~e e~bodied and it i-int~nded that th- append-d claims be construod to include alternative Qmbodiments of th~ lnvontion excspt lnsorar as llmitod by the prlor art

Claims (39)

1. An apparatus for chronic oxygen therapy supplying supplemental oxygen to a patient from a portable supply of relative low pressure oxygen which is capable of being carried by such patient, and which oxygen is capable of being introduced uniformly at relatively low pressure and relatively low flow rates into both of the lungs of such patient on a continuous long term daily basis by conduction of supplemental oxygen into the cervical trachea through a permanent surgically formed opening in the neck of the person to an oxygen supply location in the trachea suffi-ciently remote from the carina to permit adequate mixing of the oxygen introduced with the air from a normally spontane-ously breathing patient, the apparatus comprising:
elongated flexible tube means having a durometer of from about 70 to about 90 Shore A and a length sufficient to locate a distal end portion rearwardly within the trachea of the person and above the carina, and to locate a proximate end portion outwardly of the neck for connection of the proximate end portion to an external tube means connected to a portable oxygen supply means carried by the person for supplying oxygen at relatively low pressure and relatively low flow rate;
said tube means having a continuous smooth cylin-drical outer peripheral surface and a lumen having a continuous smooth constant diameter cylindrical inner peripheral surface defining an elongated continuous cylindrical central passage of constant diameter and being made of a flexible biocompatible material having an outside diameter of about 3.5 millimeters or less and an inside diameter of between about 1.7 and 3.0 millimeters;
oxygen outlet opening means at the distal end portion of said tube means including a lower end opening facing downwardly and generally anteriorly with respect to the trachea of the patient, and a plurality of sidewall openings located in predetermined spaced relationship above said lower end opening and extending through said sidewall and facing generally forwardly toward the anterior portion of the trachea for supply-ing oxygen only in a forwardly facing direction whereby rearward flow of oxygen toward the posterior portion of the trachea is limited to prevent mucosal damage; and said tube means additionally containing reinforce-ment means for maintaining a constant lumen cross-section in said tube means by resisting restriction of said central passage in order to maintain said continu-ous constant diameter of said central passage during oxygen therapy use.

2. The invention as defined in claim 1 and wherein said oxygen outlet opening means further comprising:
inclined end surface means on the distal end portion defining an elliptical lower end opening extending between a lowermost tip portion on one rear side of said tube means and an uppermost end portion on the opposite front side of said tube means and said elliptical lower end opening facing forwardly toward the front of the trachea for directing oxygen toward the front of the trachea while restricting oxygen flow toward the back of the throat.

3. The invention as defined in claims 1 or 2 and wherein:
said plurality of sidewall openings being located at said front side of said tube means along an arc of approximately between 30 degrees to 45 degrees on either side of the central axis of said elliptical lower end opening whereby oxygen is delivered through said side wall openings along a forwardly facing arcuate supply zone having an included angle of between 60 degrees and 120 degrees.

4. The invention as defined in claim 2 and further comprising:
attachment means extending around the neck of the person for holding said tube means;
tube locating and connection means on said attach-ment means for supportively connecting said tube means to said attachment means and for locating said ellipti-cal lower end opening and said plurality of sidewall openings in said oxygen supply location.

5. A system for continuously supplying supplemental oxygen transtracheally from a portable oxygen source to supplement the spontaneous breathing of a patient suffering from chronic hypoxemia, said system comprising:

a transtracheal catheter having a subcutaneous portion and an exterior portion; said subcutaneous portion extending from said exterior portion a predetermined distance, said predetermined distance dependent upon a surgically formed opening located below the cricoid cartilage and above the manubrium of the cervical trachea in the neck of a patient for whom said system is to be used, to an area spaced above the carina in said patient; (a) said exterior portion of said transtracheal catheter having a proximate end with means on said proximate end adapted to be connected to a portable oxygen source; said exterior portion further comprising means connected to said connecting means for extending said transtracheal catheter a sufficient length for said patient to (1) view said connecting means; (2) allow ease of manipulation of said connecting means; and (3) to move said connecting means away from a collar on an article of clothing worn by said patient; (b) said subcutaneous portion of said transtracheal catheter providing a continuous flow rate up to about 8 liters per minute of oxygen from said portable oxygen source at a back pressure of less than about 2 psi; and (c) said subcutaneous portion of said transtracheal catheter being formed from a medically inert material having a durometer of between about 80 to about 90 Shore A, so as to have sufficient flexibility for long term use in said patient; (d) said transtracheal catheter further comprising oxygen outlet means on a distal end portion of said subcutaneous portion for dispersing said oxygen uniformly into the right and left bronchus of said patient without interfering and blocking said spontaneous breathing of said patient; means on said transtracheal catheter between said exterior portion and said subcutaneous portion adapted to locate said transtracheal catheter in position against said neck of said patient; and means slideably engaging said locating means on said transtracheal catheter adapted to secure said transtracheal catheter around said neck of said patient to hold said locating means against said neck thereby preventing accidental movement of said transtracheal catheter from said opening, said securing means being trimmed to have a length sufficient for said securing means to snugly fit against said neck at said formed opening.

6. The system of claim 5 wherein said subcutaneous portion of said transtracheal catheter has a continuous internal passageway and wherein said internal diameter is between about 1.7 mm and 2.5 mm.

7. The system of claim 5 wherein said extending means comprises forming said exterior portion of said transtracheal catheter outwardly from said locating means a length sufficient so said connecting means can be visibly seen by said patient over the chin of said patient so said connecting means can be easily manipulated and so said connecting means can be moved away from the collar of clothing worn by said patient, said extending means being formed from flexible material.

8. The system of claim 5 wherein said exterior portion further comprises means to resist kinking and collapsing of said transtracheal catheter.

9. The system of claim 8 wherein said transtracheal catheter comprises means imbedded within the sidewalls of said transtracheal catheter for reinforcing said sidewalls to resist kinking and collapsing of said catheter.

10. The system of claim 5 wherein said dispensing means further comprising means formed in said distal end portion to direct the flow of said oxygen away from the posterior walls of the trachea in order to minimize mucosal damage.

11. The system of claim 10 wherein said directing means comprise a beveled distal end having an elliptical end opening facing toward the anterior wall of said tracheal.

12. The system of claim 10 wherein said directing means comprise a plurality of openings formed in said distal end portion of said subcutaneous portion located longitudinally and peripherally between a 120 degree included angle on the anterior side of said subcutaneous portion.

13. The system of claim 12 wherein said directing means further comprise a beveled distal end having an elliptical end opening facing toward the anterior wall of said trachea.

14. The system of claim 5 wherein said system further comprises means to clean said transtracheal catheter while said transtracheal catheter is in place in said trachea.

15. The system of claim 14 wherein said cleaning means comprise a cleaning rod insertable by said patient through said transtracheal catheter to dispel mucus, said rod having a diameter slightly less than the internal diameter of said subcutaneous portion, a length greater than the length of said subcutaneous portion, and means on said rod preventing over extension of said rod in said transtracheal catheter.

16. The system of claim 5 wherein said subcutaneous portion comprising means to limit adhesion and subsequent build-up of mucus-like materials on the interior and exterior surfaces of said subcutaneous portion to prevent restriction of the flow of oxygen through said catheter.

17. The system of claim 16 wherein said limiting means comprise coating said interior and exterior surfaces of said subcutaneous portion with a hydrophilic material.

18. The system of claim 5 wherein said external oxygen supply is of a type to be easily carried by said patient during normal ambulatory activities.

19. The system of claim 5 wherein said portable oxygen source further comprises:

a portable oxygen tank, means for selectively engaging said patient, a first end of said reinforced tube slideably engaging said connecting means of said transtracheal catheter, the opposing end of said reinforced tube connecting to said portable oxygen tank, means connected to said reinforced tube and to said engaging means for restricting movement of said reinforced tube so that movement by said patient minimizes stress on said transtracheal catheter, said first end of said reinforcement tube being further capable of selective disengagement from said connecting means when said stress exceeds about 1-3 pounds of pull.

20. The system of claim 5 wherein said flow rate means comprise forming said subcutaneous portion with a continuous internal passageway having an internal diameter of between about 1.7 mm and 3.0 mm.

21. The system of claim 5 wherein said subcutaneous portion formed from a medically inert material having a durometer of between about 70 to about 90 Shore A.

22. The system of claim 5 wherein said subcutaneous portion is formed form a material having thermosetting characteristics when continuously subjected to body temperature to form and maintain a shape according to the particular anatomy of said trachea and said neck of said patient.

23. The system of claim 5 wherein said subcutaneous portion and said exterior portions are separably secured to said locating means.

24. The system of claim 5 wherein said external oxygen supply comprises a portable oxygen supply easily transportable by said patient.

25. A system for continuously supplying supplemental oxygen transtracheally from a portable oxygen source to supplement the spontaneous breathing of a patient suffering from chronic hypoxemia, said system comprising:

a transtracheal catheter having a subcutaneous portion and an outwardly elongated exterior portion; said subcutaneous portion extending from said exterior portion a predetermined distance, said predetermined distance dependent upon a formed opening located below the cricoid cartilage and above the manubrium of the cervical trachea in the neck of a patient for whom said system is to be used, to an area spaced above the carina in said patient; (a) said elongated exterior portion of said transtracheal catheter having a proximate end with means on said proximate end adapted to be connected to a portable oxygen source; said exterior portion being formed to extend a sufficient length for said patient to view said connecting means over the chin of said patient to allow ease of manipulation of said connecting means and so said connecting means can be moved away from a collar on clothing worn by said patient; (b) said subcutaneous portion of said transtracheal catheter providing a continuous flow rate of oxygen up to about 8 liters/min from said portable oxygen source at a back pressure of less than about 2 psi; and (c) said subcutaneous portion of said transtracheal catheter being formed from a medically inert material having a sufficient durometer so as to maintain flexibility for long term use in said patient and an internal diameter in the range of about 1.7 mm to about 2.5 mm; (d) said transtracheal catheter further comprising at least one formed opening in a distal end portion of said subcutaneous portion for dispersing oxygen into the right and left bronchus of said patient without interfering and blocking said spontaneous breathing of said patient; and an internal diameter in the range of about 1.7 mm to about 2.5 mm; means on said transtracheal catheter between said exterior portion and said subcutaneous portion adapted to locate said transtracheal catheter in position against said neck of said patient; an attachment means engaging said locating means on said transtracheal catheter adapted to secure said transtracheal catheter around said neck of said patient to hold said locating means against said neck thereby preventing accidental movement of said transtracheal catheter from said opening, said attachment means being trimmed to have a length sufficient for said attachment means to snugly fit against said neck at said formed opening.

26. A system for continuously supplying supplemental oxygen transtracheally from a portable oxygen source to supplement the spontaneous breathing of a patient suffering from chronic hypoxemia, said portable oxygen source being carried by said patient, said system comprising:

a transtracheal catheter having a subcutaneous portion and an exterior portion; said subcutaneous portion extending from said exterior portion a predetermined distance, said predetermined distance dependent upon a surgically formed opening located below the cricoid cartilage and above the manubrium of the cervical trachea in the neck of a patient for whom said system is to be used, to an area spaced above the carina in said patient; (a) said exterior portion of said transtracheal catheter having a proximate end with means on said proximate end adapted to be connected to a portable oxygen source; said exterior portion comprising an elongated flexible tube means connected to said connecting means for extending said transtracheal catheter a sufficient length for said patient to view said connecting means over the chin of said patient to allow ease of manipulation of said connecting means and to move said connecting means away from the collar of clothing worn by said patient; (b) said subcutaneous portion of said transtracheal catheter providing a continuous flow rate in a range to about 8 liters per minute of oxygen from said portable oxygen source at a back pressure of less than about 2 psi; (c) said subcutaneous portion of said transtracheal catheter having an internal diameter in the range of about 1.7 mm to about 2.5 mm; (d) said subcutaneous portion of said transtracheal catheter being formed from a medically inert material having a durometer of between about 80 to about 90 Shore A, so as to have sufficient rigidity for insertion and sufficient flexibility for long term use in said patient; (e) said transtracheal catheter further comprising oxygen outlet means on a distal end portion of said subcutaneous portion for dispersing said oxygen uniformly into the right and left bronchus of said patient by directing the flow of said oxygen away from the posterior wall of said trachea so as to minimize mucosal damage; means on said transtracheal catheter between said exterior portion and said subcutaneous portion adapted to locate said transtracheal catheter in position against said neck of said patient; a chain slideably engaging said locating means on said transtracheal catheter for securing said transtracheal catheter around said neck of said patient to hold said locating means against said neck of thereby preventing accidental movement of said transtracheal catheter from said opening, said chain being trimmed to have a length sufficient for said chain to snugly fit against said neck at said formed opening; and means selectively engaging said transtracheal catheter for cleaning said transtracheal catheter by said patient while said transtracheal catheter is in said patient.

27. The system of claim 26 wherein said exterior portion further comprises means to resist kinking and collapsing of said transtracheal catheter.

28. The system of claim 27 wherein said transtracheal catheter comprises means imbedded within the sidewalls of said transtracheal catheter for reinforcing said sidewalls to resist kinking and collapsing of said catheter.

29. The system of claim 26 wherein said directing means comprises a beveled distal end having an elliptical end opening facing toward the anterior wall of said trachea.

30. The system of claim 26 wherein said directing means comprise a plurality of openings formed in said distal end portion of said subcutaneous portion located longitudinally and peripherally between a 120 degree included angle on the anterior side of said subcutaneous portion.

31. The system of claim 30 wherein said directing means further comprises a beveled distal end having an elliptical end opening facing toward the anterior wall of said trachea.

32. The system of claim 26 wherein said cleaning means comprises a cleaning rod insertable by said patient through said transtracheal catheter to dispel mucus, said rod having a diameter slightly less than the internal diameter of said subcutaneous portion, a length greater than the length of said subcutaneous portion, and means on said rod preventing over extension of said rod in said transtracheal catheter.

33. The system of claim 26 wherein said subcutaneous portion comprising means to limit adhesion and subsequent build-up of mucus-like materials on the interior and exterior surfaces of said subcutaneous portion to prevent restriction of the flow of oxygen through said catheter.

34. The system of claim 33 wherein said limiting means comprises coating said interior and exterior surfaces of said subcutaneous portion with a hydrophilic material.

35. The system of claim 26 wherein said portable oxygen source further comprises:

a portable oxygen tank, engaging means for selectively engaging said patient, a first end of said reinforced tube slideably engaging said connecting means of said transtracheal catheter, the opposing end of said reinforced tube connecting to said portable oxygen tank, means connected to said reinforced tube and to said engaging means for restricting movement of said reinforced tube so that movement by said patient minimizes stress on said transtracheal catheter, said first end of said reinforcement tube being further capable of selective disengagement from said connecting means when said stress exceeds about 1-3 pounds of pull.

36. A system for continuously supplying supplemental oxygen transtracheally from a portable oxygen source to supplement the spontaneous breathing of a patient suffering from chronic hypoxemia, said system comprising:

a transtracheal catheter having a subcutaneous portion and an exterior portion; said subcutaneous portion extending from said exterior portion a predetermined distance, said predetermined distance dependent upon a surgically formed opening located below the cricoid cartilage and above the manubrium of the cervical trachea in the neck of a patient for whom said system is to be used, to an area spaced above the carina in said patient; (a) said exterior portion of said transtracheal catheter having a proximate end with means on said proximate end adapted to be connected to a portable oxygen source; (b) said subcutaneous portion of said transtracheal catheter providing a continuous flow rate to about 8 liters per minute of oxygen from said portable oxygen source at a back pressure of less than about 2 psi; and (c) said subcutaneous portion of said transtracheal catheter being formed from a medically inert material having thermosetting characteristics when continuously subjected to body temperature to form and maintain a shape according to the particular anatomy of said trachea and said neck of said patient; (d) said transtracheal catheter further comprising oxygen outlet means on a distal end portion of said subcutaneous portion for dispersing said oxygen uniformly into the right and left bronchus of said patient without interfering and blocking said spontaneous breathing of said patient; means on said transtracheal catheter between said exterior portion and said subcutaneous portion adapted to locate said transtracheal catheter in position against said neck of said patient; and means slideably engaging said locating means on said transtracheal catheter for securing said transtracheal catheter around said neck of said patient to hold said locating means against said neck thereby preventing accidental movement of said transtracheal catheter from said opening, said securing means being trimmed to have a length sufficient for said securing means to snugly fit against said neck at said formed opening.

37. The system of claim 36 wherein said exterior portion is formed to extend a sufficient length for said patient to view said connecting means over the chin of said patient to allow ease of manipulation of said connecting means and to allow said connecting means to be moved away from the collar of clothing worn by said patient; said elongated exterior portion (i) allowing periodic removal of said transtracheal catheter from said neck, (ii) allowing periodic cleaning of said transtracheal catheter while inserted and (iii) allowing periodic insertion and reconnection of said connection means to said portable oxygen source by said patient thereby making said transtracheal catheter suitable for long term outpatient use.

38. The system of claim 36 wherein said subcutaneous portion of said transtracheal catheter having an internal diameter in the range of about 1.7 mm to about 2.5 mm.

39. The system of claim 36 wherein said exterior portion further comprises means to resist kinking and collapsing of said transtracheal catheter.